Kyowa Kirin Co., Ltd. TSE:4151

Kyowa Kirin : Launches LUMICEF® Subcutaneous Injection 210 mg Pen in Japan

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Source: MarketScreener







Kyowa Kirin Launches LUMICEF®Subcutaneous Injection 210 mg Pen in Japan

Tokyo, Japan, November 19th, 2025 -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and COO: Abdul Mullick) today announced the launch in Japan of a new formulation of LUMICEF®(KHK4827, generic name: brodalumab [genetic recombination]) - the LUMICEF®Subcutaneous Injection 210 mg Pen.

LUMICEF®was first approved in Japan in July 2016 as the "LUMICEF®Subcutaneous Injection 210 mg Syringe" and became available for self-injection in September 2017. Approved in June 2025, the new "LUMICEF®Subcutaneous Injection 210 mg Pen" is a pen-type auto-injector prefilled with the same formulation as the syringe. The device allows injection by simply removing the cap and pressing it against the skin, which facilitates ease of use. The needle cover locks automatically after administration, helping prevent needlestick injuries. For patients who self-administer, this new option is expected to enhance both safety and convenience.

LUMICEF®is a fully human anti-interleukin-17 (IL-17) receptor A antibody that selectively binds to IL-17RA, inhibiting the biological activity of inflammatory cytokines including IL-17A, IL-17A/F, IL-17F, and epidermal cell-derived IL-17C. In Japan, it was approved in July 2016 for the treatment of psoriasis (psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma) inadequately responsive to existing therapies. Subsequent approvals included ankylosing spondylitis and non-radiographic axial spondyloarthritis in November 2020, and palmoplantar pustulosis in August 2023. LUMICEF®remains the only anti-IL-17 receptor antibody approved for these indications. Clinical trials have demonstrated its rapid onset of action, long-term safety1-3, and positive impact on patient-reported outcomes (PROs)* in real-world clinical practice4-13.



The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.





* About Patient-Reported Outcome

It refers to the patient's own evaluation and report of symptoms and complaints, rather than an evaluation by the physician. Symptoms involving subjective judgments are sometimes misaligned between the physician's and the patient's evaluations. Incorporating the patient's own evaluation will lead to a correct assessment of the drug's efficacy.

Reference

  1. Papp K. A., et al. A prospective phase III, randomized, double -blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016; 175(2): 273-286.

  2. Nakagawa H, et al. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016; 81(1) : 44-52.

  3. Lebwohl M. G., et al. Efficacy, safety, and patient-reported outcomes in patients with moderate-to-severe plaque psoriasis treated with brodalumab for 5 years in a long-term, open-label, phase II study. Am. J. Clin. Dermatol. 2019; 20: 863-871.

  4. Imafuku S, et al. Utility of the Dermatology Life Quality Index at initiation or switching of biologics in real-life Japanese patients with plaque psoriasis: Results from the ProLOGUE study. J Dermatol Sci. 2021; 101(3): 185-193.

  5. Imafuku S, et al. Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: The ProLOGUE study. J Dermatol Sci. 2022; 105(3): 176-184.

  6. Miyagi T, et al. Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study. JAAD Int. 2022; 8: 146-153.

  7. Ohata C, et al. Difference in health-related quality of life between anxiety and depressive symptoms in Japanese patients with plaque psoriasis: the ProLOGUE study. J Eur Acad Dermatol Venereol. 2022; 36(1): e57-e59.

  8. Ohata C, et al. Effectiveness of long-term treatment with brodalumab on anxiety or depressive symptoms in Japanese patients with psoriasis: the ProLOGUE study. Dermatol Ther (Heidelb). 2023; 13: 1039-1052.

  9. Honma M, et al. Itching and skin pain in real-life patients with plaque psoriasis: baseline analysis of the ProLOGUE study. J Dermatol Sci. 2022; 105(3): 189-191.

  10. Honma M, et al. Effectiveness of brodalumab in improving itching and skin pain in Japanese patients with psoriasis: The ProLOGUE study. J Dermatol. 2023; 50(4): 453-461.

  11. Mizutani Y, et al. Treatment with brodalumab is not associated with improved sleep problems in real-life patients with plaque psoriasis: results of the ProLOGUE study. J Dermatol. 2023; 50(3): 319-326.

  12. Saeki H, et al. Work productivity in real-life employed patients with plaque psoriasis: Results from the ProLOGUE study. J Dermatol. 2022; 49(10): 970-978.



  13. Imafuku S, et al. Plain Language Summary of Publication: The ProLOGUE study investigating brodalumab in people with plaque psoriasis: Ther Adv Chronic Dis. 2025; 16: 1-22.